Probiotic and Influenza Vaccination to Reducing Influenza-like Illness Incident in Elderly

Phase 4

Completed

• Conditions: Influenza-like Illness
• Interventions: Other: Placebo Vaccine; Biological: Flubio; Dietary Supplement: Lacidofil; Other: Placebo probiotic

• Registration Number: NCT03695432
• Lead Sponsor: Indonesia University

Brief Summary

To asses the effect of the probiotic and influenza vaccination alone and combination on enhancing immune response to influenza-like illness (ILI) and reducing ILI incidence in the elderly

Detailed Description

To see percetange of subjects seroconvertion and seroprotection before and after intervention in the elderly (\>60 years), and monitored for 6 months.

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-04
• Study Completion: 2016-07
• Study First Submitted: 2018-09-28
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-02
• Last Update Submitted: 2018-10-03
• Study First Posted: 2018-10-04
• Last Update Posted: 2018-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 910

Inclusion Criteria

• all health elderly aged ≥ 60 years
• who came to the vaccination and health education activities in the entire East Jakarta District Health Center
• with Body Mass Index (BMI) 17,5-29,9
• healthy mental status (MMSE score of 28-30)

Exclusion Criteria

• subject who have contraindications to influenza vaccinations
• are undergoing treatment related to immune system modulation in the past 4 weeks
• therapy for immunossuppresants and/ or corticosteroids eqivalent to prednisone ≥ 20 mg/day that is being lived more than 2 weeks or has only been stopped less than 3 months before the study
• recieved influenza vaccination less than one year before
• Currently consuming probiotic agents, either in the form of a manufacturer or natural for more than 7 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo Vaccine	Placebo Vaccine	Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly
Vaccine	Flubio	Flubio (A/California/7/2009, A/Texas/50/2012 and B/Massachusetts/2/2012) Vaccine 0,5 ml for every subjects The vaccine will be given intramuscularly
Probiotic	Lacidofil	Lacidofil (Lactobacillus acidophilus Rossel-52 and Lactobacillus rhamnosus Rosell-11 with maltodextrin 211 mg, magnesium stearat 8 mg and ascorbic acid 1 mg) antibiotic
Placebo probiotic	Placebo probiotic	capsul

Primary Outcome Measures

Name	Time	Method
The precentage enhancement of the immune response to flubio vaccine and probiotic compared to plasebo 6 months after vaccination	6 months

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects with anti HI titer >=1:40	6 months	Describe seroprotection on 4-weeks, 4-months, and 6-months after interventions in elderly
Percentage subjects with increasing antibody titer >=4 times	6 months	Describe seroconvertion on 4-weeks, 4-months, and 6-months after interventions in elderly

Trial Locations

Locations (1)

Integrated Health Post, at Pulo Gadung District; 🇮🇩 Jakarta, DKI Jakarta, Indonesia